WASHINGTON, D.C. — Zimmer Biomet has initiated a Class I recall of its Comprehensive Reverse Shoulder due to devices experiencing a higher fracture rate than is stated in the labeling, the Food and Drug Administration has reported.

According to the agency’s Feb. 16 recall notice, Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers on Dec. 20.

The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. Biomet Zimmer says device is beneficial for patients with rotator cuff tears who have ...